Class I · High risk Ongoing
Vitality
Reason Marketed without an approved NDA/ANDA: Product found to be tainted with undeclared sildenafil and tadalafil.
FDA Drug Recalls
220 recalls · Class I, newest first
Class I · High risk Ongoing
PHENYLephrine added to 0.9% sodium chloride
Reason Presence of Particulate Matter
Class I · High risk Ongoing
BD ChloraPrep Clear 1mL Applicators
Reason Non-Sterility: contamination of Aspergillus penicillioides, due to breach in package lidding.
Class I · High risk Ongoing
POTASSIUM CHLORIDE Inj.
Reason Labeling: Label Error on Declared Strength. Overwrap labeled as Potassium Chloride Inj 10 mEq may contain flexible containers of Potassium Chloride Inj 20 mEq
Class I · High risk Ongoing
POTASSIUM CHLORIDE Inj.
Reason Labeling: Label Error on Declared Strength. Cases labeled POTASSIUM CHLORIDE 20 mEq, may contain flexible containers with overwrap mislabeled as 10 mEq. The correct dosage strength of 20 mEq is printed on the labeling affixed to the product flexible container.
Class I · High risk Ongoing
Fentanyl Transdermal System CII
Reason Defective delivery system - patches could be multi-stacked, adhered one on top of the other, in a single product pouch.
Class I · High risk Ongoing
SinuCleanse Soft Tip NETI POT Nasal Wash System
Reason Microbial Contamination of Non-Sterile Products: Bacterial contamination with Staphylococcus aureus
Class I · High risk Ongoing
SinuCleanse Premixed SALINE PACKETS
Reason Microbial Contamination of Non-Sterile Products: Bacterial contamination with Staphylococcus aureus
Class I · High risk Ongoing
SinuCleanse Soft Tip Squeeze Bottle Nasal Wash System
Reason Microbial Contamination of Non-Sterile Products: Bacterial contamination with Staphylococcus aureus
Class I · High risk Ongoing
Phenylephrine HCl Injection
Reason Presence of Particulate Matter.
Class I · High risk Ongoing
Prograf
Reason Failed Tablet/Capsule Specifications: Bottles shipped to the USA may contain empty capsules
Class I · High risk Ongoing
Astagraf XL
Reason Failed Tablet/Capsule Specifications: Bottles shipped to the USA may contain empty capsules
Class I · High risk Ongoing
Adrenalin Chloride Solution
Reason Labeling: Not Elsewhere Classified: misleading label similar in appearance to the FDA-approved drug product Adrenalin¿ (epinephrine injection, USP)
Class I · High risk Ongoing
Systane Lubricant Eye Drops
Reason Non-Sterility
Class I · High risk Ongoing
FOUZEE SugarLin HERBAL FORMULA capsules
Reason Marketed without an Approved NDA/ANDA; FDA laboratory analysis confirmed product tainted with undeclared metformin and glyburide
Class I · High risk Ongoing
Nhan Sam Tuyet Lien Truy Phong Hoan
Reason Marketed without an Approved NDA/ANDA: FDA analysis found the products to be tainted with undeclared Furosemide, Dexamethasone and Chlorpheniramine
Class I · High risk Ongoing
FORCE FOREVER 400mg Tablets
Reason Marketed without an approved NDA/ANDA. FDA analysis found the product to be tainted with Diclofenac and Dexamethasone.
Class I · High risk Ongoing
Clonazepam Orally Disintegrating Tablets
Reason Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister strips inside the product carton reflect the correct strength.
Class I · High risk Ongoing
Clonazepam Orally Disintegrating Tablets
Reason Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister strips inside the product carton reflect the correct strength.
Class I · High risk Ongoing
Clonazepam Orally Disintegrating Tablets
Reason Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister strips inside the product carton reflect the correct strength.
Class I · High risk Ongoing
Clonazepam Orally Disintegrating Tablet
Reason Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister strips inside the product carton reflect the correct strength.
Class I · High risk Ongoing
ZapMax Capsules
Reason Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and diclofenac.
Class I · High risk Ongoing
ZoomMax Capsules
Reason Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and diclofenac.
Class I · High risk Ongoing
PeakMax Capsules
Reason Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and diclofenac.
Class I · High risk Ongoing
VitalityXtra Capsules
Reason Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and diclofenac.